Debilitating low back paIn: multi-centre Safety and performanCe invEstigation Of CAdisc*-L, total disc ReplacemeNt therapy.

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 6

Inclusion Criteria

Subject is male or non pregnant, non-lactating female
Subject is aged between 25-65 years (inclusive)
Subject has a BMI < 35
Subjects has a preoperative ODI > 30 points
Subject has chronic low back pain, and is in the opinion of the investigator a suitable candidate for anterior lumbar surgery
Subject has completed at least 6 months of conservative treatment without obtaining adequate symptomatic relief
Subject has degenerative disc changes at a single level between L3 - L4, or L4 - L5, or L5 - S1 as confirmed by positive discography and visualised by X-Ray, CT or MRI scan and/or with one or more of the following:
i decrease in disc height < 50% (or up to 80% and no benefit of facet injections)
ii.annular thickening
iii.herniated nucleus pulpous
Subject is able to give voluntary, written informed consent to participate in this investigation and from whom written consent must be obtained prior to enrolment.
Subject who, in the opinion of the Investigator, is able to understand this investigation, co-operate with the investigational procedures and is willing to return to the hospital for all the required post-operative follow-up visits.

Exclusion Criteria

Subject has back or leg pain of unknown aetiology
Subject has radicular or sciatic pain which is more severe than low back pain
Subject has undergone previous lumbar spinal surgery which could affect the trial outcome (e.g., disc replacement)
Subject has obvious signs of psychological or worker compensation or litigation claim elements to their condition, or are actively engaged in such activities
Subject is unwilling or unable to give consent or adhere to the follow-up programme
Subject has active infection or metastatic disease
Subject has non-degenerative spondylolisthesis
Subject has degenerative spondylolisthesis > grade 1
Subject has a known allergy to any of the implant materials
Subject has osteoporosis (if suspected to be confirmed by bone density being 2.5SD below normal as assessed using DEXA analysis in post-menopausal females if suggested by X-ray or other risk factors)
Subject has osteopenia
Subject has bony lumbar stenosis
Subject has pars defect
Isolated radicular compression syndromes, especially due to disc herniation
Clinically compromised vertebral bodies at the affected level due to current or past trauma
Subject is skeletally immature as determined by the investigator
Subject has participated in another clinical investigation or study with an investigational medical device within the last 60 days
Concomitant medications that are known significantly to interfere with bone/soft tissue healing, e.g. steroids.
Subject has uncorrected iliac, aorto-iliac, or aortic aneurysm disease.
Spinal instability (> 3mm translation or > 5° angulation) confirmed by functional radiological assessment.
Subject has degenerative disc changes at the L6 - S1 level